A Prospective Blinded Pilot Study Evaluating the Sensitivity and Specificity of 18F Fluorodeoxyglucose PET CT Imaging (a Non-invasive Imaging Tool) for the Diagnosis of Rejection in Heart Transplant Recipients.
Sponsor study identifier
interventional
20
0 countries
N/A
Study Start
September 30, 2024
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Primary Completion
October 2, 2025
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Study Completion
October 2, 2026
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This pilot study aims to assess whether 18F-FDG PET CT imaging has the potential in diagnosing cardiac rejection. The investigators aim to recruit 20 heart transplant subjects within two groups of 10 subjects each. One group will have participants with definite rejection and the other group will have participants with definite no rejection. Subjects will be placed into study groups based on their heart muscle biopsy, echocardiogram, clinical symptoms, ECG, and presence or absence of donor specific antibodies. Each group will then undertake a 18F-FDG PET CT scan to identify whether this imaging modality has a role in identifying cardiac rejection. The study subjects and the research team will be blinded to the results of the PET CT until the end of the study.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2, 2026
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2, 2024
Actual (reported)July 25, 2024
Actual (reported)September 30, 2024
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October 2, 2025
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October 2, 2026
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Define the sensitivity and specificity of FDG PET CT in the diagnosis of cardiac rejection, when compared to the current clinical standard (cardiac biopsy and Echocardiography)
We aim to confirm the sensitivity and specificity of FDG PET CT in diagnosing cardiac rejection
18 months
Practicality and acceptability of FDG PET CT imaging to patients
18 months
Based on heart muscle biopsy findings. Subjects must have no significant coronary disease within the last 12 months (with a confirmatory angiogram, computed tomography coronary angiogram, myocardial perfusion scan, cardiac magnetic resonance imagining, or other coronary ischaemia test.
Based on heart muscle biopsy findings
Each participant will prepare for their study PET CT by following an initial 18 hour of zero carbohydrate diet followed by another 18 hours of fasting (water allowed). After confirming preparation, each study participant will have a single rest rubidium and 18F-FDG PET CT scan.
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Daly KP, Dearling JL, Seto T, Dunning P, Fahey F, Packard AB, Briscoe DM. Use of [18F]FDG Positron Emission Tomography to Monitor the Development of Cardiac Allograft Rejection. Transplantation. 2015 Sep;99(9):e132-9. doi: 10.1097/TP.0000000000000618.
Mansimran Dulay, MBBS MRCP
Royal Brompton and Harefield Hospital
First Submitted
May 2, 2024
First Posted
July 25, 2024
Study Start
September 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 2, 2025
Estimated (date passed)Quantitative Detection of Circulating Donor-Specific DNA in Organ Transplant Recipients (DTRT-Multi-Center Study)
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 25, 2024
Record last verified: 2024-07
There are no plans to share individual participant data (IPD)
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Source: ClinicalTrials.gov.
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